"The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with [Abbott's radiofrequency-enabled] cardiac pacemakers and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user.to access a patient's device using commercially available equipment", the agency wrote.
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The FDA and Abbott do not recommend removal of the devices, according to the safety update.
Abbott spokesperson Candace Steele Flippin says, "Abbott is resolving all old St. Jude Medical issues".
Abbott says that new pacemakers made as of 28 August will come pre-patched with the update, and both the company and FDA say that already-implanted devices should not be physically replaced due to cybersecurity concerns.
"These planned updates further strengthen the security and device management tools for our connected cardiac rhythm management devices", Hamilton said.
Making arrangements to have almost a half million patients in the US visit their healthcare provider for the firmware update "will be a logistical nightmare", he says, despite Abbott and the FDA recommending that patients wait until their next regular appointment with physicians to do the update.
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Recommendations include an in-person visit with the patient in question's health care provider, as the update can not be done online. The risks, which include reloading previous firmware due to an incomplete installation, loss of now programmed settings and loss of device functionality all occur at rates well below 1%.
The FDA alert says the recall involves implantable cardiac pacemakers, including cardiac resynchronization therapy pacemakers under the names Accent, Anthem, Accent MRI, Accent ST, Assurity and Allure. The update process will take approximately 3 minutes to complete.
The update is for pacemakers with radio frequency (RF) telemetry capabilities, meaning that they are wirelessly connected by radio waves for recording and transmitting the readings of the devices.
"If we do find them, we could look at it as a reason not trust the devices, or we could look at it like we're going from a mode of silent failures to one where we're starting the process to inform smarter and better designs", Corman said.
Doctors will now get a warning should batteries run to dangerously low levels thanks to the new software updates. If deemed appropriate, install the firmware update following the instructions on the programmer.
"For pacing dependent patients, consider performing the cybersecurity firmware update in a facility where temporary pacing and pacemaker generator can be readily provided", according to the alert.
One year ago, research firm Muddy Waters first said the St. Jude pacemakers were vulnerable to cyberattacks.
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